Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: [Docket No. FDA-2014-N-0297] Comments on “Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation”
To whom it may concern,
As members of the Patient, Consumer, and Public Health Coalition, which includes nonprofit organizations and individuals that represent patients, consumers, physicians, scientists, and researchers, we welcome the opportunity to comment on the Food and Drug Administration’s proposed order to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III and surgical mesh instrumentation from class I to II. The Coalition is dedicated to evidence-based medicine that is used to improve the health and safety of patients and consumers.
We are writing to express our strong support for the FDA’s proposal to upclassify both surgical mesh for POP repair and surgical mesh instrumentation. This change will help to ensure that devices intended to improve women’s heath are supported by evidence of safety and effectiveness. We would also like to express our strong concerns that the agency has not proposed reclassification of surgical mesh for stress urinary incontinence (SUI) from class II to class III. All transvaginal surgical mesh products – no matter the indication – should be evaluated via the premarket approval (PMA) pathway. Surgical mesh is a permanent implant, failure of which can and has caused serious adverse health consequences for hundreds of thousands of women. Reclassification of both indications would be the best way to ensure that the transvaginal surgical mesh products women rely on are safe and effective by establishing consistency across the device review process.
Support for Reclassification of Surgical Mesh for POP Repair
We commend the FDA for proposing this reclassification in response to the high number of adverse events associated with transvaginally placed surgical mesh and the consequent recommendation to upclassify from the FDA’s Obstetrics & Gynecology Devices Advisory Panel in 2011. In the last three years alone, the agency has received nearly 20,000 adverse event reports for surgical mesh for POP repair. These adverse events are both far too common and severe, including organ perforation and hemorrhage, pain, infection and additional surgeries. Women deserve better from medical device manufacturers, and they count on the FDA to establish standards that result in better outcomes. The devices marketed to and used by women should be supported by strong evidence that they are safe and effective.
In addition to information about the significant harm associated with surgical mesh, the FDA’s proposed order provided valuable information that can help women and providers understand the limited effectiveness of surgical mesh for POP repair compared to traditional repair. The proposed order states that “the published literature reveals that, although transvaginal POP repair with mesh often restores anatomy, it has not been shown to improve clinical benefit over traditional non-mesh repair.” The success of POP repair surgeries is often based on a measurement of ideal anatomic support, rather than on whether the surgery improved a women’s symptoms and quality of life. As a result, many trials purport to show that POP repair using mesh is effective; however, the benefit of surgery using mesh disappears when success is measured by outcomes that matter to women. A device should actually improve women’s health and quality of life, not just improve the number on an anatomy measurement scale.
Given the serious harms and lack of meaningful benefit of using surgical mesh for POP repair, we strongly agree with the FDA’s determination that class II general and special controls are not sufficient to ensure the safety and effectiveness of these devices. Both the Advisory Panel and the agency noted the lack of rigorous, long-term data for surgical mesh products, despite having been on the market for more than a decade. The proposed order to upclassify surgical mesh for POP repair will require manufacturers to submit these devices for a PMA review, which will give the FDA the opportunity to ensure that companies provide, and the agency evaluates, premarket clinical data. We strongly support the upclassification of these devices from class II to class III.
Support for Reclassification of Surgical Mesh Instrumentation
We support the proposed order to reclassify surgical mesh instrumentation from class I to class II. In the evaluation of adverse events associated with surgical mesh, the agency found that there are also serious harms associated with the instrumentation used during procedures with surgical mesh. These harms included damage to blood vessels, nerves, and tissue that may have been caused by improperly designed surgical mesh instrumentation; damage to the tissue that may have been caused because of non-biocompatible materials in the instrumentation; and infection that may have been caused by inadequate sterilization. Because instrumentation is currently class I, there is minimal regulation of these devices despite the fact that they are used in surgery and are causing serious harm to women.
When women undergo surgery, they expect that the devices used to operate on them have been reviewed by the FDA to ensure that they are properly designed, compatible with use in the human body and sterile. These adverse events are unacceptable and demonstrate that class I general controls cannot ensure the safety and effectiveness of surgical mesh instrumentation. Women and healthcare providers depend on the FDA to ensure that the devices they use for surgery are safe, effective and supported by evidence. We strongly support the upclassification of these devices from class I to class II.
Recommendation to Reclassify Surgical Mesh for SUI Repair
We strongly oppose the FDA’s decision not to include surgical mesh for SUI repair in the class II to class III reclassification order. Women should have evidence that surgical mesh is safe and effective regardless of whether it is for POP or SUI repair. Although the FDA did not include surgical mesh for SUI repair in this proposed order, the agency review documents from the 2011 Advisory Panel meeting show that some FDA staff who reviewed the data were concerned about the rate and severity of adverse events reported in the literature and to the agency. They concluded that pre and post-market studies on the safety and effectiveness of mesh for SUI repair are necessary to adequately evaluate the product – a conclusion shared by the Advisory Panel.
Several Panel members also noted that the totality of the data on surgical mesh for SUI is weak and consequently there is not enough information available for women to make informed treatment decisions. The Panel agreed that the agency should require preclinical studies if a mesh product is in any way different from a current product – which is a significantly higher standard than that required to demonstrate substantial equivalence, the standard for products being considered under the 510(k) process. The Panel specifically recommended that the FDA require a one-year pre-market randomized clinical trial and post-market surveillance for any new mesh product. This combination essentially describes the requirements for a product undergoing a PMA review, as a class III product would do.
We are particularly concerned about the loophole created by the split classification – mesh for POP will go through the PMA review while mesh for SUI will only have to go through the 510(k) process. Sponsors could exploit the disparity in standards that would result from reclassifying mesh for one indication without reclassifying for another, very similar, indication. Several panel members raised concerns about this possibility in 2011, noting the likelihood that a disproportionate number of future applications would be for an SUI indication instead of a POP indication because it will be easier to meet the lower standard and that surgeons will then continue to use the products for both indications, regardless of the labeled indication. Upclassification for this indication would prevent that. We urge the FDA to reclassify surgical mesh for SUI from class II to class III.
In conclusion, we greatly appreciate the agency’s work on this proposed order. We strongly support for the FDA’s proposal to upclassify surgical mesh for POP repair and surgical mesh instrumentation. However, we strongly urge the agency to strengthen the proposed order to upclassify mesh for SUI repair from class II to class III as well. We support higher scientific standards of approval and more robust post-market surveillance of implanted devices – this is particularly necessary for transvaginal surgical mesh products, which have a history of recalls due to severe, permanent side effects including crippling pain, infections, and additional surgeries. Women suffering with POP and SUI deserve options that are safe and effective – not the false hope offered by implants that leave them with new, and more devastating health problems.
American Medical Women’s Association
Annie Appleseed Project
Breast Cancer Action
Center for Medical Consumers
Connecticut Center for Patient Safety
National Health Research Center
National Women’s Health Network
Our Bodies Ourselves
Truth in Medicine Incorporated